Job description

QC Environmental Monitoring Associate
The QC EM Association will conduct environmental monitoring (EM) according to Standard Operating Procedures (SOPs) in a cleanroom facility. In this role, you will use sophisticated laboratory instrumentation and computer systems to collect and record environmental monitoring data and also receives and ships in-process and final product samples. Additionally, you will perform preventative maintenance of laboratory equipment and process and evaluate environmental monitoring samples according to SOPs. You will apply knowledge of Good Documentation Practices (GDP) and Current Good Tissue Practices (cGTP) on a daily basis. Lastly, this person will also assist with metric reporting for EM duties, data trending and analysis, investigation writing, and audit support.
Responsibilities:

• Performs microbiological monitoring duties including viable air, viable surfaces, and non-viable particulate sampling of clean room facility.
• Receives, incubates, and reports results from environmental monitoring samples.
• Receives samples into QC and ships samples for testing to external labs.
• Performs water and steam sampling of USP water system.
• Initiates investigations for deviations and out of specification test results.
• Maintains required QC records and logs.
• Maintains EM equipment such as cleanings and other preventative maintenance as required.
• Reviews data associated with environmental monitoring testing and reports anomalies.
• Assist with the EM lab upkeep and EM data archiving on a daily basis.
• Reads, understands and follows SOPs to comply with all applicable regulations
• Interacts effectively with company management and internal departments.
• Performs gown certifications

Education
Bachelors Degree, ideally in a scientific discipline
Experience

• Minimum 1 year work experience within the biotechnology or pharmaceutical industry
• Proficiency in other compliance disciplines, i.e., cGTP, GLPs, GDP, GxPs

Competencies

• Quality focused and results oriented
• Competent with strong problem solving abilities
• Excellent organizational, written and verbal communication skills
• Experience with Microsoft based applications, and ability to learn internal computer systems
• Good documentation skills
• Flexibility and ability to adjust to changing priorities and unforeseen events; excellent time management skills
• Ability to work consistently in a fast-paced environment with little supervision
• Good interpersonal skills and the ability to work effectively and efficiently in a team environment.
• Ability to work flexible hours, including possible off-shifts and weekends.

Work Environment

• Office, Cleanroom , and Lab Environment

Physical Requirements

• Must be able to get gown certified and perform certifications
• Must be able to gown into clean room to perform environmental monitoring duties
• Must be able to lift 40 pounds repeatedly
• Must be able to perform routine EM sampling off schedule

About Us:
Smith+Nephew has a proud history of more than 160 years of improving health around the world. Whilst we have grown significantly from our beginnings as a small family pharmacy in Hull, England, our caring spirit has remained the same.
Care, Collaboration, & Courage:
Care means that we show empathy and understanding for each other, our customers and patients.
Collaboration means we work together as a team, based on mutual trust and respect.
Courage is about continuous learning, innovation and accountability.
At Smith+Nephew, we offer competitive and rewarding compensation and benefits packages!
Our benefits packages vary from country to country and by level, but often the total package includes the following:

• A competitive salary with an annual bonus plan.
• Strong Healthcare coverage.
• A competitive company retirement benefit scheme for all employees.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

Job Type: Full-time

Pay: $25.00 - $29.00 per hour

Schedule:

• 8 hour shift

Work Location: One location

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